Merck Associate Director Quality in West Point, Pennsylvania

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

The MMR Integrated Product Team (IPT) Quality Operations Leader reports to the Live Virus Vaccine Manufacturing End to End (E2E) Quality Operations Director and is responsible for implementing Divisional, Company, and Site policy, procedures, and guidelines and for discharging Quality Operations responsibilities within the IPT. These activities are associated with all Quality aspects associated with the IPT's manufacturing, including product release, deviation management, environmental monitoring, change control and compliance. The MMR IPT Quality Operations Leader manages a team responsible for the release of all manufactured MMR Bulk Vaccine products within the IPT. They ensure that products are produced using approved processes in conformance to all applicable regulatory requirements and Company policies. In order to effectively manage Quality Operations within the IPT, the IPT Leader must demonstrate excellent leadership abilities with strong quality, analytical, and scientific skills. Effective collaboration, communication, decision-making, and talent management are required capabilities. The IPT Quality Operations Leader also participates in regulatory inspections and is a member of the IPT Leadership Teams and the E2E LVV Quality Leadership Team.

Primary activities:

  • Responsible for managing and coaching the IPT Quality staff (6 Specialists) and administering personnel policies and development programs. Ensures that the IPT Quality Operations personnel operate safely and comply with established policies/procedures of the Division and Corporation and too all applicable governmental regulations (GMP, EPA, etc.), both domestic and foreign.

  • Acts as the primary Quality Operations contact for the IPT and represents the IPT on key governance committees including Tier meetings, Technical/Operations Review, and relevant Fact Finding Committees. As such, they must have sound knowledge of a wide variety of processes, analytical understanding, instrumentation, and automation disciplines associated with MMR Bulk Vaccine manufacturing.

  • Ensures that all products produced in the IPT are in conformance to all applicable policies/procedures of Merck, in compliance with cGMPs, and in compliance with all governing regulations.

  • Proactively partners with Operations and Technology to identify continuous improvement opportunities to reduce lead-time and decrease waste while maintaining a strong quality management system within the IPT.

  • Reviews and classifies Event Notifications within the IPT, and ensure that deviation investigations have thorough root cause analysis and timely closure. Also reviews and approves CAPAs, regulatory commitments, change requests, and protocols and final reports within the IPT.

Education Minimum Requirement:

  • Bachelor's degree in science, engineering, or related areas of study.

Required Experience and Skills:

  • At least five (5) years’ experience in the Pharmaceutical industry

  • At least two (2) years’ in a supervisory/management capacity

Preferred Experience and Skills:

  • Aseptic/sterile processing experience

  • Previous Quality Operations experience in Pharmaceutical, Biologics, Vaccines, or Therapeutic Protein manufacturing

  • Vaccine manufacturing experience and/or Quality Systems experience

  • Demonstrated leadership and management experience working with cross-functional teams on complex projects

  • Demonstrated proven leadership experience with domestic and international regulatory agencies in a compliance/inspection setting

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

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Job Quality Operations

Title: Associate Director Quality

Primary Location: NA-US-PA-West Point

Requisition ID: QUA008709